Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-000001-23
    Sponsor's Protocol Code Number:14861B
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-000001-23
    A.3Full title of the trial
    An open-label extension study to evaluate the long-term
    safety and tolerability of Lu AE58054 as adjunctive
    treatment to donepezil in patients with mild-moderate
    Alzheimer's disease
    Estudio de extensión abierto para evaluar la seguridad y la tolerabilidad a largo plazo de Lu AE58054 como tratamiento complementario a donepezilo en pacientes con enfermedad de Alzheimer leve o moderada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term Safety and Tolerability of Lu AE58054 as Adjunctive Treatment to donepezil in Patients With Mild-moderate Alzheimer's Disease
    Seguridad y tolerabilidad de Lu AE58054 como tratamiento complementario a donepezilo en pacientes con enfermedad de Alzheimer leve o moderada
    A.4.1Sponsor's protocol code number14861B
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLundbeck España S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportH. Lundbeck A/S
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLundbeck España S.A.
    B.5.2Functional name of contact pointlundbeckclinicaltrials@lundbeck.com
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Diagonal, 605, 9º
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08028
    B.5.3.4CountrySpain
    B.5.4Telephone number900834586
    B.5.6E-maillundbeckclinicaltrials@lundbeck.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLu AE58054
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeLu AE58054
    D.3.9.4EV Substance CodeSUB114522
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code Lu AE58054
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeLu AE58054
    D.3.9.4EV Substance CodeSUB114522
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer´s disease
    Enfermedad de Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer´s disease
    Enfermedad de Alzheimer
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety and tolerability of Lu AE58054 as adjunctive therapy to donepezil in patients with mild-moderate AD.
    Evaluar la seguridad y la tolerabilidad a largo plazo de Lu AE58054 como tratamiento complementario de donepezilo en pacientes con EA leve o moderada.
    E.2.2Secondary objectives of the trial
    To evaluate the disease development during long-term treatment with Lu AE58054 as adjunctive therapy to donepezil.
    Evaluar el desarrollo de la enfermedad durante el tratamiento a largo plazo con Lu AE58054 como tratamiento complementario de donepezilo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? The patient has completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A or 14862A.
    - El paciente ha completado Visita 7 (Finalización Visita) en los estudios clínicos de pre inclusión doble ciegos controlados con placebo 14861A ó 14862A.
    E.4Principal exclusion criteria
    ? The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator.
    ? The patient has experienced seizures before Completion Visit in the lead-in study.
    ? The patient has evidence of clinically significant disease.
    ? The patient's donepezil treatment is likely to be interrupted or discontinued during the study.
    ? The patient is receiving therapy with another AChEI or memantine.
    - El paciente presenta un acontecimiento adverso moderado o intenso persistente desde el estudio de preinclusión que el investigador considera un posible riesgo para la seguridad.
    - El paciente ha tenido crisis epilépticas antes de la visita de finalización del estudio de preinclusión.
    - El paciente presenta signos de una enfermedad clínicamente significativa.
    - Es probable que haya que interrumpir o suspender el tratamiento con donepezilo del paciente durante el estudio.
    - El paciente está recibiendo tratamiento con otro IAC o con memantina.
    E.5 End points
    E.5.1Primary end point(s)
    ? Safety: Number of adverse events
    ? Tolerability: Number of withdrawals
    -Seguridad: Número de acontecimientos adversos
    -Tolerabilidad: Número de retiradas
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 28 weeks and a 4-week safety follow-up
    Hasta 28 semanas y 4 semanas de seguimiento de la seguridad.
    E.5.2Secondary end point(s)
    ? Change in cognition: Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score
    ? Change in global impression: Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score
    ? Change in functioning: Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score
    ? Change in behavioural disturbance: Change in Neuropsychiatric Inventory (NPI) total score
    ? Change in cognitive aspects of mental function: Change in Mini Mental State Examination (MMSE)
    ? Risk of Suicidality Using C-SSRS Scores: Columbia Suicide Severity Rating Scale (C-SSRS)
    -Cambio de la cognición: Cambio en la puntuación total de la Escala de evaluación de la enfermedad de Alzheimer-subescala cognitiva (ADAS-Cog).
    -Cambio en la impresión global: Escala del Alzheimer?s Disease Cooperative Study-Impresión clínica global del cambio (ADCS-CGIC).
    - Cambio de funcionamiento: Cambio en la puntuación total de la Escala del Alzheimer?s Disease Cooperative Study-actividades cotidianas (ADCS-ADL23).
    -Cambio en la alteración del comportamiento: Cambio en la puntuación total del Inventario neuropsiquiátrico (NPI).
    - Cambio en los aspectos cognitivos de la función mental: Cambio en el Miniexamen cognoscitivo (MEC).
    - Riesgo de suicidio usando las puntuaciones C-SSRS: Escala de valoración del riesgo de suicidio de Columbia (C-SSRS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Week 28 for all, except for Risk of Suicidality which is up to week 28.
    Momento basal y Semana 28 para todas, excepto para el Riesgo de Suicidio que es hasta la semana 28.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA108
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Croatia
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Ireland
    Israel
    Italy
    Korea, Republic of
    Lithuania
    Poland
    Portugal
    Romania
    South Africa
    Spain
    Taiwan
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 265
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1505
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects with Alzheimer´s disease
    Pacientes con Enfermedad de Alzheimer
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 802
    F.4.2.2In the whole clinical trial 1770
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The 28 week treatment period will be followed by a 4 week safety follow up period without treatment with IMP
    El período de tratamiento de 28 semanas es seguido por un período de seguimiento de la seguridad de 4 semanas sin tratamiento con el PI.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-06
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Oct 31 06:52:27 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA